Effect of MTX Discontinuation on Shingrix Response in RA
- Registration Number
- NCT06574594
- Lead Sponsor
- Konkuk University Medical Center
- Brief Summary
The goal of this clinical trial is to learn if methotrexate discontinuation affect on immunogeneity of shingrix in RA patients. The main questions it aims to answer are:
Discontinuation of methotrexate after shingrix immunization increase efficacy of the vaccine in patients with RA ?
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- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
- fulfill 2010 ACR/EULAR classification criteria for rheumatoid arthritis
- age over 19 years
- methotrexate user
- agree for vaccination with shingrix
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Exclusion Criteria
- have other form of inflammatory arthritis or autoimmune-mediated disease
- malignancy, current infection, pregnancy
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MTX discontinuation Methotrexate methotrexate stop for 2 weeks after each shingrix vaccination MTX continuation Methotrexate -
- Primary Outcome Measures
Name Time Method Cell-mediated immunity (CD4+ and CD8+ T cell against herpes zoster) baseline (before 1st vaccination), 1 months later from 2nd vaccination, 3 months later from 2nd vaccination
- Secondary Outcome Measures
Name Time Method , Humoral immunity (anti-VZV antibody, anti-gE antibody) baseline (before 1st vaccination), 1 months later from 2nd vaccination, 3 months later from 2nd vaccination
Trial Locations
- Locations (1)
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of